§ 331.13 Restricted experiments.

(a) An individual or entity may not conduct or possess products resulting from the following experiments unless approved by and conducted in accordance with the conditions prescribed by the Administrator: (1) Experiments that involve the deliberate transfer of, or selection for, a drug or chemical resistance trait to select agents that are not known to acquire the trait naturally, if such acquisition could compromise the control of disease agents in humans, veterinary medicine, or agriculture. (2) Experiments involving the deliberate formation of synthetic or recombinant nucleic acids containing genes for the biosynthesis of select toxins lethal for vertebrates at an LD[50]<100 ng/kg body weight. (b) The Administrator may revoke approval to conduct any of the experiments in paragraph (a) of this section, or revoke or suspend a certificate of registration, if the individual or entity fails to comply with the requirements of this part. (c) To apply for approval to conduct any of the experiments in paragraph (a) of this section, an individual or entity must submit a written request and supporting scientific information to the Administrator. A written decision granting or denying the request will be issued.